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Evaluation of Colorectal Cancer Screening Strategies in China

Sponsor
Shandong University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05440552
Collaborator
(none)
20,000
Enrollment
2
Arms
17
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Qualitative Fecal immunochemical test + APCS score
  • Diagnostic Test: Quantitative Fecal immunochemical test
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Evaluation of Colorectal Cancer Screening Strategies in Chinaļ¼šA Prospective Randomized Trial
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Risk score1

Diagnostic Test: Qualitative Fecal immunochemical test + APCS score
Risk stratification using Qualitative Fecal immunochemical test and APCS score
Active Comparator: Risk score2

Diagnostic Test: Quantitative Fecal immunochemical test
Use Quantitative Fecal immunochemical only for risk stratification

Outcome Measures

Primary Outcome Measures

  1. Detection rate [up to 30 months]

    Detection of intestinal lesions

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • 50-74 years old

  • Informed consent is available

Exclusion Criteria:

  • Previous colorectal cancer

  • Previous colorectal resection

  • Previous received cancer-related treatment (except non-melanoma skin cancer)

  • Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years

  • Fecal occult blood or fecal DNA was performed within one year

  • Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (> 10% of baseline weight - Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yanqing Li, Vice President of Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier:
NCT05440552
Other Study ID Numbers:
  • 2022SDU-QILU-107
First Posted:
Jul 1, 2022
Last Update Posted:
Jul 1, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Jul 1, 2022